Test element coding apparatuses, systems and methods

• US 8,789,756 B2
• Filed: 11/11/2010
• Issued: 07/29/2014
• Est. Priority Date: 02/25/2006
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Austera, John T., Joseph, Abner D., Harttig, Herbert, List, Hans, Roesicke, Bernd, Kocherscheidt, Gerrit, Thoes, Bruno, Riggles, Randall, Ashour, Jean-Michel
• Primary Examiner(s): Savusdiphol, Paultep
• Application Number:
  US12/944,390
• Publication Number:
  US 20110132778A1
• Time in Patent Office: 1,356 Days
• Field of Search: 235/462.01, 235/462.05, 235/462.09, 235/462.08, 235/462.1, 235/462.11, 235/462.13, 235/462.32, 235/462.41, 235/462.42, 235/462.43, 235/486, 235/435, 235/439, 235/454, 235/494, 235/487
• US Class Current: 235/462.05
• CPC Class Codes: B01L 3/54 Labware with identification means identification of carriers, materials or components in automatic analysers G01N35/00732
• CPC Class Codes: G01N 2035/00148 Test cards, e.g. Biomerieux or McDonnel multiwell test cards
• CPC Class Codes: G01N 2035/00851 process control parameters
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G01N 35/02 using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations G01N35/0098 and G01N35/0099 take precedence
• CPC Class Codes: G06K 1/12 otherwise than by punching
• CPC Class Codes: G06K 19/06037 multi-dimensional coding
• CPC Class Codes: G06K 19/06046 Constructional details
• CPC Class Codes: G06K 7/14 using light without selection of wavelength, e.g. sensing reflected white light G06K7/10831 - G06K7/1097 take precedence
• CPC Class Codes: G06K 7/1417 2D bar codes
• CPC Class Codes: G06K 7/1443 locating of the code in an image
• CPC Class Codes: G06K 7/1473 error correction

Abstract

Certain exemplary embodiments include a test element operable to receive a sample and to provide an indication of an analyte of the sample to a meter. In one form test element comprises a substrate and an optically readable pattern provided on the substrate which encodes information relating to the test element.

Claims

1. An apparatus comprising:

a test element operable to receive a sample and to provide an indication of an analyte of the sample to a meter, the test element comprising a substrate and an optically readable pattern provided on the substrate and encoding information relating to the test element, the substrate having an optical transmittance relative to a light source, the optically readable pattern comprising one or more opaque marked portions and one or more unmarked portions, the optically readable pattern being readable under stationary transillumination by the light source as a shadow image projected onto a sensor;

wherein the test element comprises a second optically readable pattern configured to encode different information relating to the test element than the information encoded by said optically readable pattern, and the second optically readable pattern is readable under transillumination by the light source during a portion of the manufacturing of the test element, and unreadable under transillumination by the light source at the completion of manufacturing.

2. The apparatus according to claim 1 wherein a transillumination optical pathway through the test element is defined by and consists essentially of the substrate and the optically readable pattern.

3. The apparatus according to claim 1 wherein the test element comprises a sample chamber, a reagent, a working electrode, and a counter electrode, and the test element is operable to receive a sample in the sample chamber, react the sample with the reagent, and provide an indication of an analyte of the sample when the working electrode and the counter electrode are electrically coupled with the meter.

4. The apparatus according to claim 1 wherein the optically readable pattern comprises an information density of about 64 bits per square millimeter or greater.

5. The apparatus according to claim 1 wherein the optically readable pattern comprises a conductive material disposed on a surface of the substrate and defining one or more void regions exposing the substrate.

6. The apparatus according to claim 1 wherein the information relating to the test element includes calibration information relating to a reagent.

7. The apparatus according to claim 1 wherein the information relating to the test element includes slope information, intercept information, lot information, and expiration information.

8. The apparatus according to claim 1 further comprising the meter, the light source, and the sensor.

9. The apparatus according to claim 8 wherein the meter is configured to receive the test element, the light source is configured to illuminate a portion of a first surface of the test element received by the meter, and the sensor configured to detect light transmitted through the test element.

10. The apparatus of claim 9 wherein the light source faces a first side of the test element when the test element is received by the meter and the detector faces a second side of the test element opposite the first side when the test element is received by the meter.

11. The apparatus according to claim 1 wherein the information encoded by the optically readable pattern remains recoverable when up to about 30% of the pattern is damaged.

12. The apparatus according to claim 1 wherein a transillumination optical pathway through the test element consists of the substrate and the optically readable pattern.

13. The apparatus according to claim 12 wherein the substrate consists of a single piece.

14. The apparatus according to claim 1 wherein the test element includes a sample receptacle configured to receive the sample and the optically readable pattern is positioned at a location of the substrate spaced apart from the sample receptacle.

15. The apparatus according to claim 1 wherein the second optically readable pattern is configured to encode information uniquely identifying the test element among a set of test elements.

16. The apparatus according to claim 15 wherein the information relating to the test element encoded by said optically readable pattern is based at least in part upon the uniquely identifying information encoded by the second optically readable pattern.

17. A system comprising:

a test element configured to receive a sample and to provide an indication of an analyte of the sample, the test element comprising a transparent or translucent substrate, an opaque pattern provided on the substrate to encode information relating to the test element, an optical pathway through the test element consisting essentially of the substrate and the pattern, a second opaque pattern provided on the substrate to encode second information relating to the test element, and a second optical pathway through the test element consisting essentially of the substrate and the second opaque pattern, wherein the second opaque pattern is readable by directing light through the second optical pathway to a sensor during a portion of the manufacturing of the test element and unreadable by directing light through the second optical pathway to the sensor source at the completion of manufacturing; and

a measurement device configured to interface with the test element to receive the indication of the analyte of the sample, the measurement device comprising an optical source configured to provide light to the optical pathway and an optical sensor configured to receive light from the optical pathway.

18. The system according to claim 17 wherein the test element comprises an electrochemical test element.

19. The system according to claim 18 wherein the information relating to the test element includes information of a reagent of the electrochemical test element.

20. The system according to claim 17 wherein the information relating to the test element includes information to calibrate the measurement device to the test element.

21. The system according to claim 17 wherein the pattern has an information density of about 96 bits per square millimeter or greater.

22. The system according to claim 17 wherein the pattern comprises an area less than about one square millimeter.

23. The system according to claim 17 wherein the test element comprises a single use electrochemical test element having a sample chamber, a reagent, and a working electrode, and a counter electrode, and wherein the test element is operable to receive a sample in the sample chamber, react the sample with the reagent, and provide an indication of an analyte of the sample upon the working electrode and the counter electrode being electrically coupled with a meter.

24. The system according to claim 17 wherein a light path between the optical source and the test element is folded.

25. The system according to claim 17 wherein the optical source provides light to the optical pathway at a first surface of the test element and the pattern is provided on a second surface of the test element substantially opposing the first surface.

26. The system according to claim 17 wherein the optical source is positioned on a first side of the test element and the detector is positioned on a second side of the test element.

27. A method comprising:

providing a meter comprising a light source and an optical sensor;

providing a test element comprising a substrate, a matrix pattern provided on the substrate, an optical pathway consisting essentially of the substrate and the matrix pattern, the optical pathway comprising one or more regions having optical transmittance relative to the light source and one or more regions being substantially opaque relative to the light source a second matrix pattern provided on the substrate, and a second optical pathway consisting essentially of the substrate and the second matrix pattern, the second optical pathway comprising one or more second matrix pattern regions having optical transmittance relative to the light source and one or more second matrix pattern regions being substantially opaque relative to the light source;

reading information encoded by the second matrix pattern by directing light through the second optical pathway at an intermediate point during manufacture of the test element, wherein the information encoded by the second matrix pattern to the meter is not transferable to the meter by directing light through the second optical pathway upon completion of manufacture of the test element;

transferring information encoded by the matrix pattern to the meter by directing light from the light source to the optical pathway and detecting light emitted from the optical pathway with the detector; and

testing a sample for an analyte using the test element, the meter, and the transferred information.

28. The method according to claim 27 wherein the testing includes providing a sample to the test element and evaluating an electrical response of the test element based at least in part upon the transferred information.

29. The method according to claim 27 wherein the test element comprises a sample chamber, a reagent, a working electrode, and a counter electrode, a sample is received by the sample chamber prior to the testing, and the meter is coupled with the test element to provide electrical communication between the meter and the working electrode and between the meter and the counter electrode during the testing.

30. The method according to claim 27 wherein the directing light from the light source to the optical pathway includes directing light to a first surface of the test element with an optical system.

31. The method according to claim 27 further comprising providing a second test element comprising a second substrate and a second matrix pattern provided on the second substrate, and substantially repeating the transferring and testing acts using the second test element.

32. The method according to claim 31 wherein a second matrix pattern encodes information to alter meter operation relative to operation with the first test element.